December 7, 2021
By David Jensen, Staff Writer, MasterControl
Receiving a warning letter involves action items and additional correspondence with the U.S. Food and Drug Administration (FDA). All of which delays your company in getting product out the door. Learn some of the common reasons life sciences companies receive FDA warning letters, so you can avoid making the same mistakes.
October 12, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Form 483 inspectional observation reports from the FDA result in painful and costly nightmares for pharmaceutical companies. Learn the top five reasons the agency issues Form 483s and find out best practices for steering clear of them.
May 19, 2021
By Dale Thompson, Staff Writer, MasterControl
All eyes are on contract manufacturers to help make COVID-19 vaccinations available throughout the globe. Increased scrutiny of the industry has brought an issue to the forefront: maintaining product quality while working at a rapid pace. With a modern manufacturing solution, it’s possible to prioritize both.
August 23, 2018
By Sarah Beale, Staff Writer, MasterControl
All dietary supplement companies must comply with the CGMPs outlined in 21 CFR Part 111. However, doing this and recording it is easier said than done. The top 5 violations recorded by the FDA show which areas need the most improvement and how automated systems can help
July 15, 2014
By Robert Packard, Regulatory Consultant, MedicalDeviceAcademy.com
Responding in 15 days is one of seven steps on how to respond to an FDA 483 inspection observation. This blog post also includes advice from a former FDA investigator.
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